Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma

A Phase II Study of Neoadjuvant Chemotherapy + IMRT Combined With Cetuximab in Advanced T Stage of Nasopharyngeal Carcinoma

This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship between patient outcome and EGFR gene copy number, expression and mutation.

Inclusion Criteria:

• Histologic diagnosis of nasopharyngeal carcinoma
• Range from 18～69 years old
• T3-4，N0-2，M0 (AJCC 2009)
• KPS ≥ 80
• Nonmetastatic diseases
• WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
• ALT or AST < 1.5×ULN、bilirubin < 1.5×ULN
• 0Serum creatinine < 1.5×ULN

Exclusion Criteria:

• Distance metastases
• Previously treated (surgery，chemotherapy, radiation therapy，EGFR targeted therapy or immunotherapy)
• Second malignancy within 5 years
• Precious therapy with an investigational agent
• Uncontrolled seizure disorder or other serious neurologic disease
• ≥ Grade Ш allergic reaction to any drug including in this study
• Clinically significant cardiac or respiratory disease
• Creatinine clearance < 30ml/min
• Drug or alcohol addition
• Do not have full capacity for civil acts
• Severe complication, active infection
• Concurrent immunotherapy or hormone therapy for other diseases
• Pregnancy or lactation